InnovHeart Saturn TMVR Device Used in FIH Transseptal Implantation

May 30, 2024—InnovHeart s.r.l, a developer of transcatheter mitral valve replacement (TMVR) systems for the treatment of mitral regurgitation (MR), announced the first transseptal clinical trial implantation with the company’s Saturn transcatheter mitral valve. The Saturn TMVR system is limited to investigational use and is not commercially available in any country.

The initial procedure was performed as part of CASSINI-EU, an ongoing European clinical trial that will expand to multiple countries and enroll up to 30 patients with moderate-to-severe or severe MR.

The FIH procedure was conducted by the heart team of Kęstutis Ručinskas, MD, et al at Santaros Klinikos University Hospital in Vilnius, Lithuania, and supported by Torsten Vahl, MD, et al.

The patient was a female in her late 70s with severe mixed (degenerative and functional) MR. Excellent hemodynamic results were reported for the patient, advised the company.

“We were honored to work with this outstanding international team providing life-changing novel TMVR therapy for this high-surgical-risk patient,” commented Giedrius Davidavičius, MD, in InnovHeart’s press release. “It is particularly rewarding to support the InnovHeart progression from transapical to transseptal delivery of the Saturn valve at our institute.” Dr. Davidavičius is with the heart team at Santaros Klinikos.

Dr. Vahl added, “This first case is a critical step to validate that the Saturn valve can be successfully delivered via a fully percutaneous, transfemoral, transseptal approach. The Saturn prosthesis has a unique modular design comprising an annular ring and low-profile valve that can reverse remodel the native annulus, avoid left ventricular outflow tract obstruction, and eliminate MR.” Dr. Vahl is with the Structural Heart and Valve Center, NewYork-Presbyterian Hospital, Columbia University Irving Medical Center in New York, New York.

Paolo Denti, MD, with San Raffaele University Hospital in Milan, Italy, is Principal Investigator for CASSINI-EU and was part of the support team during the initial procedure.

In InnovHeart’s press release, Dr. Denti stated, “Overall, this important case demonstrates that the Saturn valve can be successfully implanted with either retrograde or antegrade approaches. It is exciting to add transseptal delivery and begin to expand the clinical experience for the Saturn valve beyond the initial transapical study, now in long-term follow-up. I continue to believe that Saturn will become a valuable new therapy with fewer anatomical exclusions than other technologies, with the potential to treat a wider range of patients.”